Trial Outcomes & Findings for Mitochondrial Function in Circulating Cells and Muscle Tissue (NCT NCT02700698)

NCT ID: NCT02700698

Last Updated: 2021-12-01

Results Overview

Skeletal muscle (m.vastus lateralis) and peripheral blood mononuclear cell (PBMC) mitochondrial respiration were determined in response to substrate inhibitor coupling protocols using high resolution respirometry. From this, mitochondrial respiration in leak and coupled states, and reserve respiratory capacity were determined in mitochondria from skeletal muscle and from PBMCs. It was determined whether mitochondrial function in circulating cells is related to that measured in the muscle tissue of the same subjects.

• Recruitment status: COMPLETED
• Target enrollment: 35 participants
• Primary outcome timeframe: During the visit, approximately 0.5 days
• Results posted on: 2021-12-01

Participant Flow

Participant milestones

Measure	Healthy Lean Healthy lean women, 25-35 years	Overweight/Obese +/- IR Overweight/obese and/or insulin resistant women, 25-35 years
Overall Study STARTED	17	18
Overall Study COMPLETED	16	18
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Healthy Lean Healthy lean women, 25-35 years	Overweight/Obese +/- IR Overweight/obese and/or insulin resistant women, 25-35 years
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Mitochondrial Function in Circulating Cells and Muscle Tissue

Baseline characteristics by cohort

Measure	Healthy Lean n=17 Participants Healthy lean women, 25-35 years	Overweight/Obese With/Without IR n=18 Participants Overweight/obese with/without insulin resistant women, 25-35 years	Total n=35 Participants Total of all reporting groups
Age, Customized 25-35 years	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Sex/Gender, Customized Female	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	18 participants n=7 Participants	35 participants n=5 Participants
BMI	22.4 kg/m^2 STANDARD_DEVIATION 1.4 • n=5 Participants	35.6 kg/m^2 STANDARD_DEVIATION 7.0 • n=7 Participants	29.2 kg/m^2 STANDARD_DEVIATION 8.4 • n=5 Participants

PRIMARY outcome

Timeframe: During the visit, approximately 0.5 days

Population: Out of the 35 enrolled, 32 participants had all samples (paired blood and muscle samples). Thus, they were their own controls, and for the main question about correlation between circulating cells and muscle mitochondrial respiration, samples were all analyzed together. This enabled comparison of circulating cells/muscle mitochondria respiration along a spectrum of BMIs and insulin resistance.

Skeletal muscle (m.vastus lateralis) and peripheral blood mononuclear cell (PBMC) mitochondrial respiration were determined in response to substrate inhibitor coupling protocols using high resolution respirometry.

From this, mitochondrial respiration in leak and coupled states, and reserve respiratory capacity were determined in mitochondria from skeletal muscle and from PBMCs. It was determined whether mitochondrial function in circulating cells is related to that measured in the muscle tissue of the same subjects.

Outcome measures

Measure	Healthy Lean n=16 Participants Healthy lean women, 25-35 years	Overweight/Obese +/- IR n=16 Participants Overweight/obese and/or insulin resistant women, 25-35 years
Mitochondrial Function in Circulating Cells and Muscle Tissue in Young Women PBMC ATP linked respiration	26.48 pmol O2/min per 400K cells Standard Error 2.54	30.46 pmol O2/min per 400K cells Standard Error 2.44
Mitochondrial Function in Circulating Cells and Muscle Tissue in Young Women PBMC max respiration	120.04 pmol O2/min per 400K cells Standard Error 11.88	140.43 pmol O2/min per 400K cells Standard Error 14.30

Adverse Events

Healthy Lean

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Overweight/Obese +/- IR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elisabet Borsheim, PhD

University of Arkansas for Medical Sciences; Arkansas Children's Research Institute

Phone: 501-364-3053

Email: EBorsheim@uams.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place